Eurasian Economic Union proposes decentralized and harmonized device registrations
Eurasian Economic Union proposes decentralized and harmonized device registrations
A common market in medical device registration for the member countries of the new Eurasian Economic Union is being discussed in a consultation posted by the Russian Federation on 3 September. The consultation (G/TBT/N/Rus/38), which was issued under the auspices of the World Trade Organization’s committee on technical barriers to trade, gives interested parties in the three member EEU countries – Belarus, Kazakhstan and Russia – until 1 November to file their views on the proposals. The consultation document, entitled: «Draft Agreement on common principles and rules of medical devices circulation in the Eurasian Economic Union» proposes moving towards a common market for medical devices circulation in the EEU. This was one element of the Treaty on the Eurasian Economic Union, signed on 29 May 2014.
Regarding medical devices, the consultation has certainly set its ambitions high. Nadezhda Lazovskaya, an associate with Moscow-based legal firm, the Pepeliaev Group, sums this up for Skrip regulatory affairs. «Given that each state has a different regulatory system, considerable harmonization work remains to be done in order to establish the common market. To this end, there is a need for unified rules to be devised for the circulation, manufacturing, registration and labelling of medical devices, and also for oversight of quality control systems”. The quality element is a keystone of the draft agreement, which advocates international practice on quality in medical devise regulation, says Ms Lazovskaya.
